The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will be measured by specific clinical rating scales based on the assessment of negative symptoms. A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes shall include collateral effects evaluation, anxiety and depressive scales as well as clinical monitoring.

Active tDCS as foreseen in research protocol: daily sessions for 10 days with 2mA intensity stimulation during 20 minutes.

Procedure: Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation. Daily sessions with a total of 10 days intervention. Each intervention will take place with a 2mA intensity during 20 minutes. The current will be delivered by "Chattanooga Iontophoresis Dual Channel Delivery Device", that stands for a 2-channels tDCS device in which previous dosage can be set as default to maintain frequently used treatment parameters. Main features include (a) Beeping alerts if electrode fault for open current or high impedance, low battery, treatment completion or power left on; (b)automatic 30 second current ramp up and down during power on/off keeps patient comfortable; (c) Current can be set in 0.1 mA increments between 0.5 mA and 4 mA.

Placebo Comparator: tDCS sham

Sham tDCS : as foreseen in research protocol: sham stimulation with initial stimulation followed by turning off the device during the same time of intervention as to guarantee blinding

Procedure: Transcranial Direct Current Stimulation (tDCS)

Transcranial Direct Current Stimulation. Daily sessions with a total of 10 days intervention. Each intervention will take place with a 2mA intensity during 20 minutes. The current will be delivered by "Chattanooga Iontophoresis Dual Channel Delivery Device", that stands for a 2-channels tDCS device in which previous dosage can be set as default to maintain frequently used treatment parameters. Main features include (a) Beeping alerts if electrode fault for open current or high impedance, low battery, treatment completion or power left on; (b)automatic 30 second current ramp up and down during power on/off keeps patient comfortable; (c) Current can be set in 0.1 mA increments between 0.5 mA and 4 mA.

Detailed Description:

Overview

The present study is a double-blind randomized clinical trial in which patients should be allocated from a General Psychiatry Service into two groups (tDCS-active x tDCS-sham). Subjects who fulfilled eligibility criteria will undergo ten days of consecutive stimulation (active or sham) and will return after two to four weeks for final clinical assessment. Patients who shown no response in rating scales and that were allocated to sham intervention group will be able to choose whether or not they want to undergo the active intervention at follow up (partial cross-over)

Eligibility

Ages Eligible for Study:

18 Years to 59 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

patients with age between 18-59 years

diagnostic of Schizophrenia or Schizoaffective Disorder as stated by DSM-IV and confirmed by SCID (Structured Clinical Interview for DSMIV), to be tested by a psychiatrist

presence of suicidal behavior (planning or attempt in the previous 4 weeks)

pregnancy

incapacity of coping with the informed consent

specific tDCS limitations (such as anatomic problems)

Regarding medication: all patients should have stable dosology of medications for at least 6 weeks

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623726